Pre-eclampsia and Metabolomics

NCT00939575 | Unknown

• 1 other identifier: 08-173
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The hypertensive disorders of pregnancy are the medical complications more prevalent during pregnancy. In Canada, approximately 1% of pregnancies have complications due to a pre-existing hypertension, 5-6% because of hypertension of pregnancy without proteinuria and 1-2% by preeclampsia. Metabolomics involves a new technology to investigate small molecules that characterize biochemical pathways of interest. The change in concentration levels of these molecules in various biological samples such as urine and blood in the presence of a disease or a patient can be particularly useful for identifying new biomarkers. Our hypothesis is that metabolic patterns in blood and urine of pregnant women who had preeclampsia differ from the metabolomics patterns of patients without preeclampsia.The whole research program has two complementary objectives in order to expect a decrease of prematurity: a) better understanding of all the physiological mechanisms leading to prematurity and b) better identification of patients at high risk for a better management of these women.

Conditions

Preeclampsia

Keywords

preeclampsia, metabolomics, blood, urine

Outcome Measures

Primary Outcomes (1)

• comparison between the metabolic patterns of women hospitalized for preeclampsia and the control group

  between diagnosis of preeclampsia (or equivalent gestational age) and delivery

Secondary Outcomes (2)

• Longitudinal comparison of metabolomics patterns of the same individual

  between diagnosis of preeclampsia and 2 months after delivery

• Compare metabolomics patterns of pregnant women with preeclampsia early (<34 weeks) during pregnancy to those women with pre-eclampsia later during pregnancy (≥34 weeks of gestation).

  between diagnosis of preeclampsia and delivery

Study Arms (2)

Preeclampsia

Women hospitalized for pre-eclampsia after 20 0/7 weeks of gestation. The diagnosis of preeclampsia include a combination of the following criteria: after 20 weeks of gestation in a previously normotensive woman, a diastolic blood pressure \> 90 mmHg recorded twice at least four hours apart or \> 110 mmHg, with proteinuria \> 300 mg/24h or \> 30 mg / mmol protein / urinary creatinine in a urine sample or factor (s) serious maternal / fetal (according to SOGC consensus ).

control

Women will be matched to women with pre-eclampsia according to gestational age at diagnosis of preeclampsia, maternal age (in stratum of 5 years), gender, ethnicity (4 categories: Caucasian, black, Asian and other) and body mass index (5 classes: \<20, 20-25, 26-30, 31-35 and \<35). Patients of this group should be at low risk of obstetric complications at recruitment and planning to deliver at the CHUS.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

women who deliver at the CHUS

You may qualify if:

• Case group: Women hospitalized for pre-eclampsia after 20 0/7 weeks of gestation. The diagnosis of preeclampsia include a combination of the following criteria: after 20 weeks of pregnancy in a previously normotensive woman, a diastolic blood pressure ≥ 90 mmHg recorded twice at least four hours apart or ≥ 110 mmHg, with proteinuria ≥ 300 mg/24h or ≥ 30 mg / mmol protein / urinary creatinine in a urine sample or factor (s) serious maternal / fetal (according to consensus SOGC).
• Control group: Women will be matched to women with preeclampsia according to gestational age at diagnosis of pre-eclampsia, maternal age (in stratum of 5 years), gender, ethnicity (4 categories: Caucasian, black, Asian and other) and body mass index (5 classes: \< 20, 20-25, 26-30, 31-35 and \< 35). Patients of this group should be at low risk of obstetric complications at recruitment and planning to deliver at the CHUS.

You may not qualify if:

• \- Minor patients, patients with post-partum preeclampsia, premature rupture of membranes, a severe congenital fetal malformation, twin pregnancies and fetal death. Patients with underlying diseases taht could be associated with preeclampsia as pre-existing hypertension (ie before 20SA), anti-phospholipid syndrome, lupus, type DM 1-2, nephropathy, etc will be excluded. Patients who have a complication during the pregnancy will be excluded from the control group.

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Foundation of the Stars: collaborator

Study Sites (1)

Centre hospitalier de l'Université de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood and urine are collected

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Jean-Charles Pasquier, MD, PhD

  Centre hospitalier de l'Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

• Christiane Auray-Blais, PhD

  Centre hospitalier de l'Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pr

Study Record Dates

• First Submitted: July 14, 2009
• First Posted: July 15, 2009
• Study Start: March 1, 2009
• Primary Completion: February 1, 2017
• Study Completion: March 1, 2017
• Last Updated: March 4, 2015

Record last verified: 2015-03

Locations

CA (1)